- Novo Nordisk Inc. (Durham, NC)
- …Engineer role will provide support & management of hardware & software on quality control laboratory computer systems . This includes improving reliability ... of the QC lab computer systems to meet current & projected...Perform system assessments & testing of operating systems , software, & hardware Perform automation/IT validation … more
- Merck & Co. (Lower Gwynedd, PA)
- …and operational and informational technology systems .Apply deep expertise in the computer system validation process of lab equipment, including the ... equipment (from onboarding and maintenance to retirement), and manage and improve the computer system validation of laboratory equipment. This individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT ... meet business needs using a standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the… more
- Merck & Co. (Durham, NC)
- …manufacturing systems , in partnership with maintenance, technical operations, operations, validation , and quality personnel. Performs routine system ... Engineering, or Related Field Proficiency and a high degree of comfort in computer systems and applications:- Microsoft Office (Word, Excel and Outlook).… more
- Tris Pharma (Monmouth Junction, NJ)
- …FDA guidance documents in managing application/ system changes in accordance with computer system validation Experience implementing and leading IT change ... and overall priorities.She/he oversees day-to-day IT operations and business application system and provides leadership in management of IT Applications and… more
- Merck & Co. (Durham, NC)
- …of regulatory requirements in accordance with GMP manufacturing operations.Proficiency in computer systems and applications including but not limited to:- ... chromatography columns)-Support Equipment (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable… more
- Merck & Co. (Rahway, NJ)
- …and diagnosing of Robotics, Vision systems , PLC's, machine control systems , dual channel safety circuits, ladder logic.General computer skills including ... varies and often includes isolators, dedicated dust collectors, and wash-in-place systems to limit operator exposure.--A significant increase in the number of… more
- Merck & Co. (Rahway, NJ)
- …quality deliverables.Effective analysis and report programming development and validation , utilizing global and therapeutic area (TA) standards and following ... programming activities for Early Oncology clinical development projects.Review the quality and reliability of clinical studies using deep scientific knowledge,… more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling and stooping are required.-Proficiency in computer systems and applications including but not limited to:- ... contractors and disciplines on scheduling repairs and maintenance of equipment/utility systems .Assist with execution of calibration, automation, validation and… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (North Wales, PA)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Fujifilm (College Station, TX)
- … Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- System One (Warren, NJ)
- …and experience with GMP, Quality and compliance. + Previous experience as a computer system validation / quality assurance for life sciences ... in asset management software (eg Blue Mountain RAM) and quality systems software (eg Veeva). + Drives...Veeva). + Drives use of best practices during IT systems design, validation , and use. + Must… more
- Lilly (Lebanon, IN)
- …related field + 1+ years of relevant work experience in information technology, engineering, computer system validation , quality control support or ... that solution requirements comply + Deliver and support laboratory systems stack to start up new quality ...FDA regulations for pharmaceutical manufacturing. + Solid knowledge of Computer System Validation process +… more
- IQVIA (Greensboro, NC)
- …of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems , and Technology ... Manage/oversee quality events updates in the electronic quality management system (eQMS) and/or maintain the...compliant with 21CFR Part 11. + Expert knowledge of Computer Systems Validation (CSV) in… more
- Lilly (Indianapolis, IN)
- …assistance and mentorship in the execution of change controls, equipment qualification, process validation , computer system quality , deviations, and ... position provides quality oversight of the Production Quality System in support of operations, including...+ Knowledge of cGMPs, Production Processes, Quality Systems , and FDA regulations + Experience supporting computer… more
- Boehringer Ingelheim (Ridgefield, CT)
- …environment (with minimum of 5 years)with focus on quality assurance and/or computer system validation . + Strong written and oral communication skills, ... and technical risks Proactive and consultative engagement of the Computer System Validation role within...and/or Engineering + Excellent knowledge of international GMP requirements, Quality systems , Quality management (EU-GMP… more
- PCI Pharma Services (Bedford, NH)
- …and guidelines (eg FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical ... with departments inside the organization to maintain and improve computer system validation processes to...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …qualification and validation activities. + Review and approve computer system related validation documents and quality system records ... daily maintenance, account management, troubleshooting and training. Additionally, you will provide quality support relative to computer systems on site,… more
- Robert Half Technology (New Haven, CT)
- …GxP regulations * Manage the entire System Development Life Cycle (SDLC) of computer systems , ensuring validation is integrated at each stage * Create ... plans, protocols, and summary reports for computer systems to ensure regulatory compliance and quality ...GxP FDA. * Proficiency in handling Computer Systems and System Validation . *… more
Related Job Searches:
Computer,
Computer System,
Computer System Validation,
Quality,
System,
System Validation,
Validation,
Validation Quality